The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair
Primary Purpose
Laparoscopic Inguinal Hernia Repair
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia
Sponsored by
About this trial
This is an interventional other trial for Laparoscopic Inguinal Hernia Repair focused on measuring inguinal hernia repair, laparoscopic inguinal hernia repair, self-gripping mesh placement
Eligibility Criteria
Inclusion Criteria:
- Elective laparoscopic inguinal hernia repair
Exclusion Criteria:
- Rejected or withdrawn consent
Sites / Locations
- Chairat SupsamutchaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
plastic sheath covering
mesh placement without plastic sheath
Arm Description
plastic sheath was prepared with the standard 9 cmx15cm self-gripping mesh. Then the meshe were folded and unfolded over or under the plastic sheaths in different directions.
self-gripping mesh were placed without plastic sheath.
Outcomes
Primary Outcome Measures
Duration
the duration of self-gripping mesh placement with plastic sheath
Secondary Outcome Measures
post operative pain: pain scores
During a preoperative visit, the patients are introduced to the concept of the visual analogue scale (VAS), which ranges from 0 = no pain to 10 = worst pain. The measure pain scores (Visual Analog Scale) in the postoperative period.
wound infection
wound infection
Full Information
NCT ID
NCT04394338
First Posted
May 7, 2020
Last Updated
September 1, 2021
Sponsor
Mahidol University
Collaborators
Ramathibodi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04394338
Brief Title
The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair
Official Title
The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
Ramathibodi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inguinal hernia is one of the most-common surgical conditions. Incidence is about 27% in males and 3% in females.The treatment of this condition is inguinal hernia repair operation which can be approached with several techniques; open hernia repair, laparoscopic hernia repair and robotic hernia repair. The current guidelines recommend the hernia repair operation with mesh placement either Lichtenstenstein operation or laparoscopic technique; transabdominal preperitoneal technique (TAPP) and totally extraperitoneal technique (TEP). In the laparoscopic approach, one of the complications that can occur is post-operative pain from the mesh fixator. So the self-gripping mesh becomes another option to decrease this incidence.However the adhesive property of the mesh is still challenging for many surgeons. Several techniques of self-gripping mesh placement were introduced. One of the popular techniques is bilateral vertical folding of self-gripping mesh which still causes some adhesive problems when introduced to the target area. This research's aim is to present a new technique of the self-gripping mesh placement which is more effective, more convenient, and decreases the time taken to place the mesh at the surgery site.
Detailed Description
A randomized control trail comparing the duration of mesh placement and surgeon satisfaction of self-gripping mesh with plastic sheath and with non-plastic sheath covering mesh. Patients with groin hernia who planned for elective laparoscopically repair hernia with self-gripping mesh at Ramathibodi Hospital, Faculty of Medicine, Mahidol University will are informed of the details of research at the outpatient department before admission. 1:1 open label randomization trail was designed dividing the patients into two groups by the study number. The operation will be done with the standard laparoscopic hernia repair technique by experienced surgeons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Inguinal Hernia Repair
Keywords
inguinal hernia repair, laparoscopic inguinal hernia repair, self-gripping mesh placement
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized control trail comparing the duration of mesh placement and surgeon satisfaction of self-gripping mesh with plastic sheath and with non-plastic sheath covering mesh. Patients with groin hernia who planned for elective laparoscopically repair hernia with self-gripping mesh at Ramathibodi Hospital, Faculty of Medicine, Mahidol University will are informed of the details of research at the outpatient department before admission. 1:1 open label randomization trail was designed dividing the patients into two groups by the study number. The operation will be done with the standard laparoscopic hernia repair technique by experienced surgeons.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
plastic sheath covering
Arm Type
Active Comparator
Arm Description
plastic sheath was prepared with the standard 9 cmx15cm self-gripping mesh. Then the meshe were folded and unfolded over or under the plastic sheaths in different directions.
Arm Title
mesh placement without plastic sheath
Arm Type
No Intervention
Arm Description
self-gripping mesh were placed without plastic sheath.
Intervention Type
Other
Intervention Name(s)
self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia
Intervention Description
to apply these to the mesh graft placement process. In the first step, plastic sheaths self-gripping mesh placement with plastic sheathwere prepared configuration with the standard 9cmx15cm self-gripping mesh. Then the meshes were folded and unfolded over or under the plastic sheaths.
Primary Outcome Measure Information:
Title
Duration
Description
the duration of self-gripping mesh placement with plastic sheath
Time Frame
5 min
Secondary Outcome Measure Information:
Title
post operative pain: pain scores
Description
During a preoperative visit, the patients are introduced to the concept of the visual analogue scale (VAS), which ranges from 0 = no pain to 10 = worst pain. The measure pain scores (Visual Analog Scale) in the postoperative period.
Time Frame
24 hours after surgery
Title
wound infection
Description
wound infection
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective laparoscopic inguinal hernia repair
Exclusion Criteria:
Rejected or withdrawn consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chairat Supsamutchai, MD
Phone
66) 0851156958
Email
pogeneral2007@hotmai.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chumpon Wilasrusmee, MD
Phone
(66)22011527
Ext
245
Email
chumpon.wil@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chairat Supsamutchai, MD
Organizational Affiliation
Ramathibodi Hospital, Mahidol University
Official's Role
Study Chair
Facility Information:
Facility Name
Chairat Supsamutchai
City
Bangkok
State/Province
Bankok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chairat Supsamutchai, MD
Phone
022011527
Ext
245
Email
pogeneral2007@hotmail.com
First Name & Middle Initial & Last Name & Degree
Chumpon Wilasrusmee, MD
Phone
022011527
Ext
145
Email
chumpon.wil@mahidol.ac.th
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Plastic Covering Method for Self-gripping Mesh Placement in Laparoscopic Inguinal Hernia Repair
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